Duns Number:069277028
Device Description: 3/8 Circle Reverse Cutting Needle (18.7mm), USP 4-0 SUPRAMID EXTRA black cable-type Nylon, 3/8 Circle Reverse Cutting Needle (18.7mm), USP 4-0 SUPRAMID EXTRA black cable-type Nylon, 36"
Catalog Number
Code PR-40B-36
Brand Name
SUPRAMID EXTRA
Version/Model Number
Code PR-40B-36
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
97045b5e-6939-4f25-bdfd-98f018be1f10
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
July 27, 2017
Package DI Number
10816848021353
Quantity per Package
12
Contains DI Package
00816848021356
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 183 |